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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K041961
Device Name SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
Applicant
SCANDIUS BIOMEDICAL, INC.
11A BEAVER BROOK ROAD
LITTLETON,  MA  01460
Applicant Contact ERIC BANNON
Correspondent
SCANDIUS BIOMEDICAL, INC.
11A BEAVER BROOK ROAD
LITTLETON,  MA  01460
Correspondent Contact ERIC BANNON
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received07/21/2004
Decision Date 10/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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